Cleared Abbreviated

ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE (K002168) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K002168 · Ronvig Instruments, Ltd. · Dental device
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Oct 2000
Decision
88d
Days
Class 2
Risk

K002168 is an FDA 510(k) clearance for the ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Ronvig Instruments, Ltd. (Dk-8721 Daugaard, DK). The FDA issued a Cleared decision on October 13, 2000 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ronvig Instruments, Ltd. devices

Submission Details

510(k) Number K002168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2000
Decision Date October 13, 2000
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.